BEUDAMED
    FDA Recall Open, Classified

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    Recall: Z-2374-2024 · Initiated May 2, 2024

    Recall

    Recall Number
    Z-2374-2024
    Event Number
    94699
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    BRY
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    May 2, 2024
    Posted
    July 17, 2024
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    Reason

    If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

    Action

    On 6/6/24, correction notices were distributed to customers who were informed that their devices had been remediated. That they had been contacted by phone in May 2024 to schedule device remediation. The firm re-configured the component manager from "installed mode" to "disabled mode" and checked if the Microsoft patch was present on each device. If the patch was identified on a device, it was removed. All devices were then configured to "managed mode" and rebooted to enable the system appropriately. Customers are asked to complete and return the response form to Email [email protected] For safety information about the system not covered in this document, call the firm's Technical Support Center at 1-800-727-6102, Phone hours: 24 hours, 7 days a week. Additional contacts include: 1) Regional Complaint Center, 1-844-823-5433 Say "Product Complaints" when prompted Mon-Fri 8:00am and 5:00pm CT, Email: [email protected] 2) Post Market Quality Field Action Operations, [email protected]

    Distribution

    Worldwide - US Nationwide distribution including in the states of OR, KS, NE, LA, ND, OK, AL, AK, WI, WV, WA, NV, PR, TX, CO, OH, CA, MO, IA, AZ, IN, AR, IL, MN, HI, NM, FL, SD, UT, NY, VA, GA, MA, NC and the countries of TW, CA.

    Quantity

    326